Xtt Betasept Antiseptic Surgical Scrub

Xtt Betasept Antiseptic Surgical Scrub
SPL v7
SPL
SPL Set ID 4a6451d7-b347-37ac-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2024-11-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (0.04 mg)
Inactive Ingredients
Gluconolactone Isopropyl Alcohol Lauramine Oxide Peg-75 Lanolin Water Tridecyl Alcohol Coco Diethanolamide

Identifiers & Packaging

Marketing Status
NDA Active Since 1993-06-01

Description

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% solution

Uses
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 51945-4

NDC 67618-200-04

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

Single Use

BETASEPT®

Antiseptic Non-Sterile Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 4 fl oz (118 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET04BTLLBLH

NDC 67618-200-08

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 8 fl oz (237 mL)

Dist. by:Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET08BTLLBLH

NDC 67618-200-16

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 16 fl oz (473 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET16BTLLBLC

NDC 67618-200-32

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 32 fl oz (946 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET32PBTLLBLC

Section 60561-8

WARNING: Cancer - www.P65Warnings.ca.gov

Warnings

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction, stop use and seek medical help right away.

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a seperate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash

  • wet hands with water
  • dispense about 5 mL of priduct into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation

  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
Do Not Use
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient

Chlorhexidine gluconate 4% solution

Other Information

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

Inactive Ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions Or Comments?

call 1-888-827-0624 (8am-5pm, EST, Mon-Fri)

When Using This Product
  • keep out of the eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider
Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing
Section 51945-4 (51945-4)

NDC 67618-200-04

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

Single Use

BETASEPT®

Antiseptic Non-Sterile Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 4 fl oz (118 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET04BTLLBLH

NDC 67618-200-08

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 8 fl oz (237 mL)

Dist. by:Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET08BTLLBLH

NDC 67618-200-16

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 16 fl oz (473 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET16BTLLBLC

NDC 67618-200-32

From the Makers of BETADINE® products

For External Use Only

Not for Retail Sale

For Professional and Hospital Use Only

BETASEPT®

Antiseptic Surgical Scrub

Chlorhexidine Gluconate 4%

Net Contents: 32 fl oz (946 mL)

Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA

©2023 Atlantis Consumer Healthcare Inc.

4BET32PBTLLBLC

Section 60561-8 (60561-8)

WARNING: Cancer - www.P65Warnings.ca.gov

Purpose

Antiseptic

Warnings

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction, stop use and seek medical help right away.

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a seperate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product and rinse under running water
  • dry thoroughly

Healthcare personnel handwash

  • wet hands with water
  • dispense about 5 mL of priduct into cupped hands and wash in a vigorous manner for 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation

  • apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing

  • thoroughly rinse the area to be cleaned with water
  • apply the minimum amount of product necessary to cover the skin or wound area and wash gently
  • rinse again thoroughly
Do Not Use (Do not use)
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

Other Information (Other information)

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions Or Comments? (Questions or comments?)

call 1-888-827-0624 (8am-5pm, EST, Mon-Fri)

When Using This Product (When using this product)
  • keep out of the eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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